Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04850937|
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
esketamine is an optical isomer of ketamine. Compared with ketamine, esketamine has the characteristics of higher effective value, stronger receptor affinity, less adverse reactions of nervous system, and pharmacokinetics is controllable.
Domestic and foreign studies have focused on the therapeutic effect of esketamine on major depression, but less attention has been paid to perioperative depression.This study intends to explore the effect of small doses of esketamine on patients with breast cancer.Postoperative depression and pain are observed.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Esketamine Drug: normal saline||Not Applicable|
This study intends to explore the effect of small doses of esketamine on patients with breast cancer.WE pay attention to :
- Safety of low-dose single intravenous injection of esketamine (1)The influence of intraoperative vital signs of patients after medication, such as blood pressure and heart rate fluctuation; (2)the duration of recovery after anesthesia; (3)postoperative adverse reactions, such as nausea and vomiting, dizziness and diplopia, respiratory depression, laryngeal spasm, delirium agitation, etc
- Effect of single intravenous injection of low-dose ketamine on postoperative depression in patients undergoing radical mastectomy (1) 1 day before surgery, 2 days, 5 days, 30 days, 90 days after surgery Hamilton Depression Scale scores; (2) The serum leptin level 1 day before surgery, 2 days after surgery and 5 days after surgery; (3) Correlation between depression scale score and leptin level
Effects of low dose esketamine on acute and chronic pain in patients undergoing radical mastectomy
visual analogue scale scores at 6, 12 and 24 hours after surgery;
visual analogue scale scores at 3, 5, 30 and 90 days after surgery;
- the number of analgesic remedies
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||180 patients will be divided into two groups according to the random number table method: control group (normal saline group),treatment group (esketamine group), 120 cases in each group.|
|Masking:||Double (Participant, Investigator)|
esketamine 10ml (5mg/ml) and normal saline 10ml were respectively set as drug A or drug B.
Without the knowledge of the experimenter, the predetermined dose of drug A or B will be given to the experimenter before induction of anesthesia, with 0.05 mL /kg for each patient.
After all samples are collected, the third party will announce the grouping and medication.
|Official Title:||Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer|
|Actual Study Start Date :||February 10, 2021|
|Actual Primary Completion Date :||April 10, 2021|
|Estimated Study Completion Date :||May 10, 2022|
Experimental: Group S
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
Placebo Comparator: Group C
The control group will receive the same amount of normal saline after anesthesia induction
Drug: normal saline
The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction
- depression score [ Time Frame: Change from Baseline score at 3 months ]
The total rough score is the sum of all the scores in the 20 items, and then the rough score is multiplied by 1.25 to take the round part to get the standard score.
An SDS score of 53 to 62 is classified as mild depression, 63 to 72 as moderate depression, and 73 or more as major depression.
- pain score [ Time Frame: Change from Baseline score at 3 months ]
visual analogue scale 0 points painless;
1 to 3 points for mild pain; 4 to 6 points moderate pain; Severe pain on a 7-9 scale; 10 points severe pain.
- The serum leptin level [ Time Frame: Change from 1 day before surgery to 90 days after surgery ]The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850937
|Contact: MA HONGemail@example.com|
|Contact: LIU M YUfirstname.lastname@example.org|
|Affiliated hospital of yangzhou university||Recruiting|
|Yangzhou, Jiangsu, China, 225100|
|Contact: Ma Hong 13675161040 email@example.com|
|Principal Investigator:||LIU M YU||Yangzhou University|